Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device.

PURPOSE

To report initial experience with safety and efficacy in the treatment of pulmonary embolism (PE) using the FlowTriever device.

MATERIALS AND METHODS

A single-center retrospective study was performed in all patients with acute central PE treated using the FlowTriever device between March 2018 and March 2019. A total of 46 patients were identified (massive = 8; submassive = 38), all with right ventricular (RV) strain and 26% with thrombolytic contraindications. Technical success (according to SIR reporting guidelines) and clinical success (defined as mean pulmonary artery pressure intraprocedural improvement) are reported, as are major device and procedure-related complications within 30 days after discharge.

RESULTS

Technical success was achieved in 100% of cases (n = 46). Average mean pulmonary artery pressure improved significantly from before to after the procedure for the total population (33.9 ± 8.9 mm Hg before, 27.0 ± 9.0 mm Hg after; P < .0001; 95% confidence interval [CI], 5.0-8.8), submassive cohort (34.7 ± 9.1 mm Hg before, 27.4 ± 9.2 mm Hg after; P < .0001; 95% CI, 5.2-9.5) and massive cohort (30.4 ± 6.9 mm Hg before, 25.4 ± 8.2 mm Hg after; P < .05; 95% CI:0.4-9.6). Intraprocedural reduction in mean pulmonary artery pressure was achieved in 88% (n = 37 of 42). A total of 100% of patients (n = 46 of 46) survived to hospital discharge. In total, 71% of patients (n = 27 of 38) experienced intraprocedural reduction in supplemental oxygen requirements. Two major adverse events (4.6%) included hemoptysis requiring intubation, and procedure-related blood loss requiring transfusion. No delayed procedure-related complications or deaths occurred within 30 days of hospital discharge.

CONCLUSIONS

Initial clinical experience using the FlowTriever to perform mechanical thrombectomy showed encouraging trends with respect to safety and efficacy for the treatment of acute central, massive, and submassive pulmonary embolism.